Abstract
In recent decades, seasonal allergic rhinitis (SAR) prevalence has increased and recent studies have shown that air pollutants, such as diesel exhaust particles (DEP), can increase inflammatory and allergic biomarkers. The aim of this study was to investigate the effects of DEP on SAR symptoms induced by ragweed and to evaluate the efficacy and safety of fexofenadine HCl 180 mg versus placebo.
This Phase 3, single-centre, sequential, parallel-group, double-blind, randomised study (NCT03664882) was conducted in an environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180 mg or placebo). Efficacy and safety were evaluated in Period 3. Primary endpoints were the area-under-the-curve of Total Nasal Symptom Score (TNSS) from baseline to hour 12 (AUC0–12) during Period 1 and Period 2; and the AUC of the TNSS from hour 2 to 12 (AUC2–12) during Period 3.
251/257 evaluable subjects were included in the modified intent-to-treat population. Least squares (LS)-mean difference (95% confidence interval [CI]) for TNSS Log AUC0−12 in Period 2 versus Period 1 was 0.13 (0.081, 0.182; p<0.0001). LS-mean difference in TNSS Log AUC2−12 for fexofenadine HCl versus placebo during Period 3 was −0.24 (−0.425, −0.047, p=0.0148). One fexofenadine HCl-related AE was observed.
SAR symptoms evoked by ragweed were aggravated by DEP. Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.
Footnotes
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Conflict of interest: A.K. Ellis reports study investigator fees from Sanofi during the conduct of the study; and grants, advisory board and speaker fees from ALK, Abello and AstraZeneca; her institution has received fees for advisory boards and speaking from Aralez; her institution has received fees for an advisory board and speaking from Baush Health; grants and her institution has received fees for advisory boards from Circassia Ltd and GlaxoSmithKline; her institution has received fees for an advisory board from Johnson & Johnson; grants, and her institution has received fees for an advisory board and speaking from Merck; her institution has received fees for an advisory board and speaking from Mylan; grants, and her institution has received fees for an advisory board and speaking from Novartis; her institution has received fees for an advisory board and speaking from Pediapharma; grants, and her institution has received fees for an advisory board and speaking from Pfizer; her institution has received fees for speaking from Boehringer Ingelheim, MEDA, Medesus and Takeda; grants from Green Cross Pharmaceuticals, Bayer LCC and Regeneron; her institution has received fees for an advisory board and speaking from Sanofi, all outside the submitted work.
Conflict of interest: M. Murrieta-Aguttes is an employee of Sanofi.
Conflict of interest: S. Furey is an employee of Sanofi.
Conflict of interest: Dr. Picard has nothing to disclose.
Conflict of interest: Dr. Carlsten has nothing to disclose.
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- Received October 30, 2020.
- Accepted January 18, 2021.
- ©The authors 2021
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